US regulators have issued a green light for GlaxoSmithKline/Theravance’s BREO Ellipta inhaler to treat asthma in adults, but permission for its use in patients aged 12 to 17 years old was not granted.
BREO is a fixed-dose combination of the inhaled corticosteroid fluticasone furoate and the long-acting beta2-agonist (LABA) vilanterol. Two strengths, 100/25mcg and 200/25mcg, have now been approved in the US for use in asthma, administered once-daily using the Ellipta dry powder inhaler.
But, in line with recent recommendations from agency advisors, the US Food ad Drug Administration has issued a complete response letter on the proposed use of the inhaler in patients aged 12-17 years, on grounds that the data submitted failed to show “adequate risk-benefit to support the approval”.
The regulator said it would need additional data to further demonstrate the safety and efficacy in this patient population before considering approval.
Breo Ellipta is already on the US market for the long-term, once-daily, maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, but is not indicated for the relief of bronchospasm.